Severe PneumoniaNCT06533514
Rapid Diagnosis of Severe Respiratory Tract Infectious Diseases and Screening of Biomarkers for Stratified Diagnosis
An observational study of Severe Pneumonia and Biomarkers, run by Chinese PLA General Hospital.
Trial summary
The purpose of this study is to clarify the biomarkers for rapid diagnosis and stratified diagnosis of severe respiratory tract infectious diseases through clinical experiments. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Pneumonia, Biomarkers
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Meets the diagnostic criteria for severe pneumonia；
Who may be able to join
- Meets the diagnostic criteria for severe pneumonia；
- Age≥18 years old and < 80 years old；
- Willing to sign informed consent for the course of the study；
Who cannot join
- Patients with intracranial hypertension, acute coronary syndrome, pleural fistula, pneumothorax, or subcutaneous emphysema;
- Pregnant and lactating patients;
- Severely hemodynamically unstable (an increase in vasopressors by more than 30% in the first 6 hours, or norepinephrine >0.5mg/kg/min);
- Those who do not consent to participate in this study；
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to clarify the biomarkers for rapid diagnosis and stratified diagnosis of severe respiratory tract infectious diseases through clinical experiments.
Read the detailed description
Methods: The relationship between relevant biomarkers and stratified diagnosis was analyzed by collecting laboratory and etiological examinations of patients with severe pneumonia.
- Conditions
- Severe Pneumonia, Biomarkers
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mild | According to the APACHE II score, SOFA score and PSI score, the enrolled patients were divided into three groups: mild, moderate and severe. | |
| moderate | According to the APACHE II score, SOFA score and PSI score, the enrolled patients were divided into three groups: mild, moderate and severe. | |
| severe | According to the APACHE II score, SOFA score and PSI score, the enrolled patients were divided into three groups: mild, moderate and severe. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between the patient's specific biomarker levels and clinical outcomes.
Treatment failure rate, Mortality rates, SOFA rating scale
Measured: 1 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe PneumoniaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533514
- Sponsor's protocol ID
- Pneumonia and Biomarkers
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnosis of Severe Respiratory Tract Infectious Diseases and Screening of Biomarkers for Stratified Diagnosis
- ClinicalTrials.gov ID
- NCT06533514
- Acronym / sponsor ID
- Pneumonia and Biomarkers
- Conditions
- Severe Pneumonia, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to clarify the biomarkers for rapid diagnosis and stratified diagnosis of severe respiratory tract infectious diseases through clinical experiments.
Detailed description
Methods: The relationship between relevant biomarkers and stratified diagnosis was analyzed by collecting laboratory and etiological examinations of patients with severe pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild | – | –According to the APACHE II score, SOFA score and PSI score, the enrolled patients were divided into three groups: mild, moderate and severe. |
| moderate | – | –According to the APACHE II score, SOFA score and PSI score, the enrolled patients were divided into three groups: mild, moderate and severe. |
| severe | – | –According to the APACHE II score, SOFA score and PSI score, the enrolled patients were divided into three groups: mild, moderate and severe. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Meets the diagnostic criteria for severe pneumonia；
Key inclusion criteria (3 listed)
- Meets the diagnostic criteria for severe pneumonia；
- Age≥18 years old and < 80 years old；
- Willing to sign informed consent for the course of the study；
Key exclusion criteria (4 listed)
- Patients with intracranial hypertension, acute coronary syndrome, pleural fistula, pneumothorax, or subcutaneous emphysema;
- Pregnant and lactating patients;
- Severely hemodynamically unstable (an increase in vasopressors by more than 30% in the first 6 hours, or norepinephrine >0.5mg/kg/min);
- Those who do not consent to participate in this study；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The relationship between the patient's specific biomarker levels and clinical outcomes.
Time frame: 1 mounth
Treatment failure rate, Mortality rates, SOFA rating scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Pneumonia and Biomarkers, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fei xie, doctor (13911385976, xiefei0522@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between the patient's specific biomarker levels and clinical outcomes. (time frame: 1 mounth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.